This invention relates to a dual container system such as a medicament-containing vial and a fluid source such as a flexible diluent container having associated means to effect sterile intermixing of the contents of the two containers by external manipulation after the containers are joined. More particularly, the present invention relates to an improved extractor for the flexible diluent container for use with a resilient undercut stopper closing the vial or the like which enhances the mechanical interlock between the vial stopper of the additive container and the extractor of the flexible diluent container without increasing the force necessary to engage the two containers. Thus the present invention enhances the reliability of engagement and activation as well as performs satisfactorily with a wide variety of stopper materials of varying resilience.
In particular, this invention is for use in systems involving packaging of a medicament and a diluent in separate containers which may be connected to one another at the time of use for convenient, safe mixing of the medicament and diluent in a sterile environment. Such container systems are known in the art and currently are sold by Abbott Laboratories of North Chicago, Ill. under the trademark ADD-VANTAGE. A number of embodiments of such systems are disclosed in U.S. Pat. No. 4,614,267 to Larkin, U.S. Pat. No. 4,784,259 to Grabenkort, U.S. Pat. No. 4,614,515 to Tripp and Larkin, and U.S. Pat. No. 4,784,658 to Grabenkort, all of which are assigned to the assignee of this invention, and all of which disclosures are hereby incorporated by reference.
In the noted system the flexible diluent container includes a tubular port which provides a means for securing thereto a stoppered medicament vial as well as a stopper removal means. The stoppers each have an undercut or shouldered recess in their exposed end. Previously the stopper removal means was composed of a truncated cone or mushroom shaped engagement element or extractor having a smooth surface and which is attached to a removable cover that covers and seals the inner end of the port. As a stoppered vial is advanced into and engaged with the port, normally by threaded interengagement, the vial stopper advances onto the extractor. The extractor thereby engages the stopper to subsequently pull the stopper from the vial when the cover is pulled from the port.
A wide variety of materials of varying hardness or resilience are used to manufacture vial stoppers since governmental approval is required for the type of material to be used with a particular medicament. Stoppers made from softer materials are susceptible to being pushed into the medicament vial during engagement by the extractor. Alternatively the extractor may be pulled out of the stopper during attempted extraction. Stoppers made from harder materials are often more difficult to engage. Difficulty of engagement between the vial stopper and port plug and in insuring the subsequent withdrawal of the stopper also is due in part to the wide variety of physical constructions of the outer surface of the vial stoppers e.g., tapered or cylindrical. Of course, the axial insertion force must be less than the force which will remove the port plug from the port closing position.
It is highly desirable to provide a diluent container with a port plug which will provide high reliability of engagement into the stoppers of vials despite variations in materials and constructions of those stoppers, to avoid pushing the stoppers into the vials and assuring withdrawal of any stopper with the extractor, and which will avoid pushing the cover off of the inner end of the port.
An important feature of this invention is that the extractor member or port plug has a universal capability of functioning with vial stoppers made from a wide variety of materials and in a wide variety of constructions. It provides very high reliability of engagement between the port plug of the flexible diluent container and vial stopper of the additive medicament vial and of subsequent withdrawal of the stopper.
It is therefore an object and advantage of the present invention to afford a diluent container with a port plug which has the aforementioned and other capabilities.